Assessment of Natural Bypasses in the Lower Limb

This study has been completed.
Sponsor:
Collaborators:
Swiss Heart Foundation
Swiss National Science Foundation
Information provided by (Responsible Party):
Christian Seiler, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01742455
First received: November 27, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

Concerning the promotion of peripheral collateral growth, clinical studies investigating new therapeutic strategies have used imprecise assessment methods and therefore determined only "weak" endpoints. In contrast to the coronary circulation, there is currently no gold standard available to document successful promotion of collateral growth in patients suffering from peripheral artery disease. Therefore, the purpose of this study is to evaluate a new invasive method to quantify arterial collateral flow in the lower extremity in patients undergoing elective coronary angiography.


Condition
Peripheral Collaterals
Arteriogenesis
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Assessment of the Peripheral Artery Collateral Circulation in Patients With and Without Coronary Artery Disease (Pilot Study)

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Pressure-derived collateral flow index (CFIp) of the superficial femoral artery [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples (routine)


Enrollment: 30
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Background: Peripheral artery disease (PAD) of the lower extremities is due to arterial obstruction leading to reduced arterial flow during exercise and/or at rest. The disease is present in approximately 4 percent of persons >40 years of age, but in 15-20 percent of those >65 years. Claudication is the major symptom and can improve with pharmacotherapy or exercise rehabilitation. In patients with disabling claudication that persist despite exercise and pharmacotherapy or with critical limb ischemia (i.e. ischemic rest pain; ulcers or gangrene at risk of major amputation), revascularization therapies are indicated. However, in about 1/4 of these patients endovascular or surgical therapy fails or is not applicable, making alternative approaches necessary.1 Thus, promotion of angiogenesis, a process triggered by ischemia with sprouting of capillaries insufficient to provide adequate blood supply to jeopardized tissues, and arteriogenesis, which refers to positive remodeling of preformed collateral arterioles, i.e. collateral growth should be applied in these patients.2, 3 Despite the fact that numerous studies during the last decade pursued the important therapeutic strategy of improving collateral function in patients with PAD, there is currently no method available to quantify collateral arterial function of the lower limb and, thus, to determine therapeutic effects. Clinical studies investigating new therapeutic strategies for the promotion of peripheral collateral growth by application of growth factors and/or exercise rehabilitation have used imprecise and inadequate assessment methods and therefore determined only "weak" endpoints. In contrast to the coronary circulation, there is currently no gold standard available to document successful promotion of collateral growth in patients suffering from PAD.

Aim: The purpose of this study in patients undergoing elective coronary angiography with or without chronic stable coronary artery disease is to evaluate a new invasive method to quantify arterial collateral flow in the lower extremity.

Main hypothesis: Quantitative assessment of peripheral arterial collaterals by pressure-derived collateral flow index (CFIp) in the lower extremities is safe and feasible.

Methodology: Prospective exploratory trial. Primary study endpoint: Pressure-derived collateral flow index (CFIp) of the superficial femoral artery.

Potential significance: The results of this study will demonstrate that the concept of collateral flow index - which has been proven by our group in the coronary circulation - is a safe and feasible method for the quantitative assessment of peripheral limb collateral function. The results of this study may serve as preliminary data for larger clinical trials investigating therapeutic promotion of collaterals in patients with PAD and provide a reliable study endpoint.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Thirty patients with stable angina pectoris electively referred for coronary angiography to our department who give written informed consent.

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Stable angina pectoris, electively referred for coronary angiography
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Rest pain, ulceration or gangrene due to PAD (Rutherford 4-6)
  • Significant stenoses (>50%) or occlusion of superficial femoral or profunda femoral artery
  • Aortoiliac occlusion or significant stenoses (>50%)
  • Aneurysm of abdominal aorta or iliac arteries
  • Acute coronary syndrome
  • Congestive heart failure NYHA III-IV
  • Severe pulmonary arterial hypertension
  • Severe hepatic or renal failure (creatinine clearance < 15ml/min)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742455

Locations
Switzerland
University Hospital Inselspital
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss Heart Foundation
Swiss National Science Foundation
Investigators
Study Chair: Christian Seiler, MD, Prof. University Hospital Inselspital, Berne
Principal Investigator: Tobias Traupe, MD University Hospital Inselspital, Berne
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Seiler, Professor and Co-Chairman of Cardiology, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01742455     History of Changes
Other Study ID Numbers: 256/09
Study First Received: November 27, 2012
Last Updated: June 17, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Peripheral artery disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Pathologic Processes

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014